With over 30 years in medical device risk management, I am committed to advancing safety in MedTech. My career began in aerospace with NASA, working on low-earth orbit spacecraft and developing a foundation in rigorous risk assessment and safety evaluation. This background launched me on a journey to work with companies ranging from MedTech giants to pioneering startups, continuously innovating and setting new benchmarks in risk management.I’ve had the privilege of educating over 10,000 MedTech professionals worldwide, on the latest knowledge and practices in safety risk management. As a Technical Fellow and educator, I serve as an affiliate professor at Drexel University, USA, and lecture at Eindhoven University of Technology in the Netherlands. My book, Safety Risk Management for Medical Devices, is both a university textbook, and foundational resource for professionals in the field.As the founder of MedTechSafety.com, I continue to provide guidance and education on ISO 14971 compliance and risk analysis. My goal is to empower the MedTech community with the tools, frameworks, and confidence to create safer medical devices—turning challenges into opportunities for innovation and improved healthcare safety.Together, we can build a world where technology serves humanity without compromising safety.
Listed skills include Medical Devices, R&D, Cross Functional Team Leadership, Design Control, and 35 others.